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[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348894
Recruitment Status : Terminated (- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.)
First Posted : July 6, 2006
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 4, 2006
First Posted Date  ICMJE July 6, 2006
Last Update Posted Date June 1, 2011
Study Start Date  ICMJE July 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
  • Vital signs [ Time Frame: duration of study ]
  • Physical examination [ Time Frame: duration of study ]
  • 12-lead ECG [ Time Frame: duration of study ]
  • Hematology/Biochemistry [ Time Frame: duration of study ]
  • Adverse events [ Time Frame: duration of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2006)
Vital signs, Physical examination, 12-lead ECG, Hematology/Biochemistry, Adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • Pain Visual Analogue Scale [ Time Frame: duration of study ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: duration of study ]
  • Modified Brief Pain Inventory-Short Form [ Time Frame: duration of study ]
  • Patient Global Impression of Change [ Time Frame: duration of study ]
  • SF-12 Health Survey [ Time Frame: duration of study ]
  • EQ-5D [ Time Frame: duration of study ]
  • Analgesic Treatment Satisfaction Scale [ Time Frame: duration of study ]
  • Pain-related Medication Utilization [ Time Frame: duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2006)
Pain Visual Analogue Scale 	 Patient Global Impression of Change Neuropathic Pain Symptom Inventory Modified Brief Pain Inventory-Short Form SF-12 Health Survey EQ-5D Analgesic Treatment Satisfaction Scale Pain-related Medication Utilization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
Official Title  ICMJE A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
Brief Summary The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: [S,S]-Reboxetine
    [S,S]-reboxetine
  • Drug: Any
    Any standard of care treatment for DPN
Study Arms  ICMJE
  • Experimental: Open Treatment
    [S,S]-reboxetine
    Intervention: Drug: [S,S]-Reboxetine
  • Standard Care
    Standard Care
    Intervention: Drug: Any
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
136
Original Enrollment  ICMJE
 (submitted: July 4, 2006)
800
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
  • Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria:

  • Patients with significant hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Croatia,   Estonia,   Finland,   Germany,   India,   Poland,   Russian Federation,   South Africa,   Sweden,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00348894
Other Study ID Numbers  ICMJE A6061031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP